Trial | NCT01012531  Report issue

Title

Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen
Efficacy and Safety of Subcutaneous Cluster Immunotherapy With Cluster-allergoid CLUSTOID Grasses/Rye (Glutaraldehyde-polymerized Allergen Extract of Mixtures of Grass and Rye Allergens) in Patients With Allergic Rhinoconjunctivitis Sensitized to Grass and With or Without Rye Pollen Sensitization

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    121
The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.
Study Started
Oct 31
2008
Primary Completion
Nov 30
2009
Study Completion
Dec 31
2009
Last Update
Jul 14
2011
Estimate

Biological Subcutaneous injection with placebo

cluster schedule

Biological Subcutaneous injections with highly polymerized allergen extract

cluster schedule

highly polymerized allergen extract Active Comparator

Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen
Positive screening skin prick test (wheal diameter > 3 mm)
Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
Signed and dated patient´s Informed Consent,

Exclusion Criteria:

Previous immunotherapy with grass and/or rye pollen extracts within the last 3 years,
Simultaneous participation in other clinical trials,
Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
Auto-immune disorders,
Severe chronic inflammatory diseases,
Malignancy,
Alcohol abuse,
Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
Patients being in any relationship or dependency with the sponsor and/or investigator,
Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
No Results Posted